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Completed

NCT Number: NCT05439395

Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure

The study is designed as a retrospective, international, multi-center cohort study to evaluate Steelex® Sternum Set for sternum closure. The data from 2 clinics located in Germany and Spain participating in the "OPTICABG" as well as in the "PREMIVALVE" study will be used for assessment. Only patients receiving a complete or a partial sternotomy closed with Steelex® Sternum Set will be included in the analysis. "OPTICABG" patients were followed up 3 months after surgery and "PREMIVALVE" patients until 6 months after surgery. Adverse Events (AE) / Serious Adverse Events (SAE)(e.g. surgical site infection, sternum stability, stroke, myocardial infraction, death etc.) reported in both studies will be used for the STERCCAS analysis.

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Key information

Conditions

Coronary Artery Disease Aortic Valve Disease Aortic Valve Stenosis Arterial Occlusive Diseases Arteriosclerosis Cardiac Valve Insufficiency Cardiovascular Diseases Coronary Disease Heart Diseases Heart Valve Diseases Myocardial Ischemia Vascular Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Robert Bosch KH Stuttgart, Stuttgart, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • OPTICABG study patients undergoing an elective, primary coronary artery bypass graft surgery (CABG) receiving a sternotomy, by whom the sternum was closed using Steelex® Sternum Set.
  • PREMIVALVE study patients undergoing a cardiac valve replacement or reconstruction receiving a complete or partial sternotomy, by whom the sternum was closed using Steelex® Sternum Set.
  • Eligible patients from the OPTICABG study and PREMIVALVE study who have provided their written informed consent
  • Age ≥18 years

Exclusion criteria

  • OPTICABG and PREMIVALVE patients receiving a sternotomy or partial sternotomy which was not closed with Steelex® Sternum Set.

Treatment and study plan

Sternum Closure after Cardiac Surgery

Device

Sternal closure using Steelex® Sternum Set after CABG or cardiac valve replacement / reconstruction.

Primary outcomes

  1. Incidence of a composite endpoint consisting of sternum instability, sternum dehiscence, superficial and deep sternal wound infection

    Time frame: up to 6 months after surgery

    Combination of:

    • Incidence of sternum instability
    • Incidence of sternum dehiscence
    • Incidence of superficial and deep sternal wound infection according to classification of Centers for Disease Control and Prevention (CDC)

Secondary outcomes

  1. Incidence of sternum instability

    Time frame: up to 6 months after surgery

    Number of patients presenting with instability of the sternum after sternal closure with Steelex® Sternum Set

  2. Incidence of sternum dehiscence

    Time frame: up to 6 months after surgery

    Number of patients presenting with dehiscence of the sternum after sternal closure with Steelex® Sternum Set

  3. Incidence of superficial and deep sternal wound infection

    Time frame: up to 6 months after surgery

    Number of patients presenting with superficial and deep sternal wound infection according to CDC classification after sternal closure with Steelex® Sternum Set

  4. Incidence of other cardiac and cerebral complications

    Time frame: up to 6 months after surgery

    Number of patients presenting with other cardiac and cerebral complications such as stroke, myocardial infarction, death, as well as mediastinitis after sternal closure with Steelex® Sternum Set

  5. Incidence of suture related complications

    Time frame: up to 6 months after surgery

    Number of patients presenting with suture related complications (e.g. wire breakage) after sternal closure with Steelex® Sternum Set

  6. Length of hospital stay

    Time frame: until discharge (approximately 10 days postoperative)

    Number of days the patient has to stay in hospital

  7. Length of intensive care unit stay

    Time frame: until discharge (approximately 10 days postoperative)

    Number of days the patient has to stay in intensive care unit after intervention

  8. Health Status measured with EQ-5D-5L Score

    Time frame: up to 6 months after surgery

    EQ-5D-5L is a Quality of Life Score introduced by the EuroQol Group. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).

    Descriptive system comprises five dimensions (5D): mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels (5L): no problems, slight problems, moderate problems, severe problems, extreme problems. Each answer results in a 1-digit number. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

    The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.

  9. Intraoperative handling of the Steelex® Sternum Set

    Time frame: at time of surgery

    the handling is examined using a survey, which will be answered and filled out prospectively and anonymously once by all involved cardiac surgeons

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Collaborators

  • B.Braun Surgical SA

Registry information

Official study title

Multi Center, International, Single-arm, Retrospective, Observational Post Market Clinical Follow-Up (PMCF) Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure in Patients Undergoing Cardiac Surgery

Acronym: STERCCAS

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jun 30, 2022
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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